This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for ivWatch Model 400: Device Validation for Non-Infiltrated Tissues (NCT02120443), a na na study. The primary outcome is Normal Tissue Red Notification Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02120443 |
| Phase | NA |
| Condition | Infiltration of Peripheral IV Therapy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 43 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ivWatch, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Adult volunteers with non-infiltrated, normal tissue at a common peripheral IV therapy site. The brief summary describes 40 adult volunteers. The registry enrollment is 43, and the primary-outcome description says three subjects were excluded from analysis because of significant protocol deviations.
Intervention
The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. It is described as a device that issues red notifications when a clinician should check an IV site.
Comparator
There was no comparator group. The record describes a single-group study, with no random allocation. This design assesses notifications during monitoring of normal tissue; it does not compare the device with another device or with a control group.
Primary question
What was the average number of red notifications per day when the device monitored non-infiltrated tissue over 24 hours? The registry describes the intended outcome and confidence-interval method, but the observed mean and its interval are not reported in the registry record.
The study focuses on device notifications in tissue characterized as normal, rather than on detection of an infiltration event. A red notification is described as indicating a need for a clinician to check the IV site; it suggests a greater likelihood of possible infiltration than a yellow notification. The primary measure therefore concerns how often the device issued this alert during the stated monitoring period. It does not, by itself, establish whether a notification corresponded to a true clinical event. The registry lists a yellow-notification rate and significant skin irritation or disruption to skin integrity as secondary outcomes, but their results are not reported in the registry record.
3. Trial Design
This was a completed, single-group device study of the ivWatch Model 400 in non-infiltrated tissue. The registry lists the study as having no phase designation, no allocation, and no masking. It reports enrollment of 43. The brief summary describes a single arm study of 40 adult volunteers, while the primary-outcome description states that three subjects were excluded from analysis because of significant protocol deviations. The record does not explain further how enrollment and the analysis population were handled.
The device monitored a common peripheral IV site over a 24 hour observation period. The primary outcome was the mean normal-tissue red-notification rate, expressed as red notifications per day, with a 95% confidence interval. Two secondary outcomes are listed: the normal-tissue yellow-notification rate and significant skin irritation or disruption to skin integrity. The registry describes three outcome measures, but it does not report their observed results.
The record gives a start date of 2014-01 and a primary completion date of 2014-01, and lists the study status as completed. It does not report a randomized comparison, a control arm, or masking. Consequently, the study design addresses the device's notification behavior in the monitored setting, rather than a difference between treatment groups. The protocol, the rationale for the enrollment target, and any sample-size justification are not reported in the registry record. The record also does not report an analysis plan or any analyses; it lists zero analyses.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Non-Infiltrated Tissue |
|---|---|
| STARTED | 43 |
| COMPLETED | 43 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Three subjects were excluded from analysis due to significant protocol deviations.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Non-Infiltrated Tissue |
|---|---|---|
| Participants analysed | 43 | |
| Age, Continuous | years | 31.4 (SD 13.9) |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 42 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 25 |
| Region of Enrollment: United States | participants | 43 |
| Body Mass Index | kg/m^2 | 26.3 (SD 5.4) |
| Skin Pigmentation | units on a scale | 1.84 (SD 0.84) |
6. Primary Endpoint
The registry lists the primary outcome as Normal Tissue Red Notification Rate, measured over 24 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | red notifications per day |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean number of red notifications per day issued by the ivWatch Model 400 while monitoring normal, non-infiltrated tissue over 24 hours. The registry describes a red notification as communicating the need for a clinician to check an IV site. It suggests an increased likelihood that infiltration may be occurring, with a greater likelihood relative to a yellow notification. Thus, the endpoint describes the frequency of a device alert under the stated monitoring conditions, not a confirmed count of infiltrations.
A rate is useful for describing how often notifications occur during a defined observation period. In this study, the day-based unit puts the outcome in terms of notification frequency, while the 24 hour timeframe specifies the monitoring period. The mean summarizes the average rate across the analyzed observations; the 95% confidence interval is intended to convey uncertainty around that estimate. The registry says the interval was calculated using the Clopper-Pearson method. The observed mean and confidence limits are not reported in the registry record, so neither the alert frequency nor its precision can be interpreted from the posted results.
Interpretation also depends on the clinical status assigned to the monitored tissue and on how notifications were evaluated. The record describes monitoring of non-infiltrated tissue but does not report an independent confirmation procedure or a measure of notification correctness. The endpoint therefore should be read as a device-output measure in this study setting, not as a diagnostic accuracy result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and specifies its unit, observation timeframe, and confidence-interval method. It does not report the observed mean red-notification rate or the endpoints of its 95% confidence interval. As a result, the posted results do not show how often red notifications occurred, how variable the estimated rate was, or how precisely that rate was estimated. A numerical conclusion about the endpoint cannot be drawn from the record.
The study has one group and monitors non-infiltrated tissue. There is no like-for-like control comparison, and the record does not describe randomization or masking. The outcome can therefore describe notifications in this study setting, but it cannot establish a difference relative to another device or group. Nor can a notification rate alone establish that alerts corresponded to actual infiltration. The registry's description says a red alert suggests an increased likelihood that infiltration may be occurring and prompts a clinician check; it does not report confirmation of events.
The record says three subjects were excluded from the primary-outcome analysis because of significant protocol deviations. It does not report the specific deviations, their timing, or how the excluded observations may differ from those analyzed. This limits assessment of how representative the analysis population was of enrolled volunteers. The record also does not explain the relationship between its enrollment figure and the 40 adult volunteers described in the brief summary beyond noting those exclusions.
Zero serious events and zero other events are listed for the non-infiltrated-tissue group, with 43 at risk in each listing. These are recorded event counts, not proof that no harms could occur. The record does not provide event descriptions, follow-up details beyond the 24 hour observation period for the device monitoring, or a fuller account of safety ascertainment. The deaths entry is null, so it should not be treated as a reported zero.
Overall, the registry describes a completed single-group device-monitoring study and states what the primary endpoint was intended to measure. Because the primary numerical result and secondary outcome results are not reported in the registry record, the actual notification frequency, its uncertainty, and the observed secondary outcomes remain unknown from the posted results. These gaps prevent interpretation of the magnitude of the measured device behavior.
9. Statistical Methods Explained
The primary endpoint is a continuous measure summarized as a mean: the normal-tissue red-notification rate, in red notifications per day. General statistical explanation: a mean describes the average of observed values, but it does not show the spread of individual observations. A confidence interval accompanies an estimate to express uncertainty about the underlying value that is compatible with the data and the method used. The registry specifies a 95% confidence interval, but does not report its limits or the mean it accompanies. Without those numbers, the estimate's precision cannot be judged.
What does the stated confidence-interval method mean?
The registry says the 95% confidence interval for the red-notification rate was calculated using the Clopper-Pearson method. This is the method identified in the record; it is not possible to verify its implementation from the information reported. General statistical explanation: Clopper-Pearson intervals are commonly associated with binomial proportions. Applying a method to a rate requires a defined statistical construction and suitable data. The registry does not report the underlying event counts, exposure details beyond the 24 hour monitoring timeframe, or calculation inputs. Thus, readers cannot independently reproduce or assess the interval from the record.
General explanation: confidence intervals are not a guarantee that a particular interval contains the true value, nor do they show the range of individual participant experiences. Their width depends on the data and the method. Here, the interval itself is absent, so it cannot be used to distinguish a tightly estimated rate from a more uncertain one. No p-value or hypothesis test result is reported for the primary outcome.
Why does the one-group design matter?
The study is listed as single-group, with no allocation and no masking. General statistical explanation: a one-group descriptive study can characterize measurements observed under its study conditions. Without a comparator, it does not estimate a between-group treatment contrast. It also cannot separate device-related notification behavior from differences in study participants, sites, procedures, or observation conditions by comparing groups. The primary endpoint is therefore best understood as a descriptive rate for the analyzed observations, not a comparative effect.
The registry describes red notifications as signals prompting a clinician to check an IV site, and says they suggest a greater likelihood of possible infiltration relative to yellow notifications. A notification count is not necessarily a count of confirmed infiltration events. General explanation: evaluating diagnostic performance generally requires comparing test outputs with a defined reference assessment. Such a reference process and measures of diagnostic performance are not reported in the registry record. The primary endpoint alone therefore does not provide sensitivity, specificity, predictive values, or accuracy.
How should the analysis population be read?
The enrollment is listed as 43, while the brief summary describes 40 adult volunteers. The primary-outcome description states that three subjects were excluded because of significant protocol deviations. The record does not specify the deviations or give additional details about the observations excluded. General statistical explanation: exclusions can affect an estimate if excluded observations differ systematically from included ones. The extent or direction of any such effect cannot be assessed without details about the deviations and relevant measurements. No imputation or other missing-data method is described.
Although a planning illustration is described in the registry, its numerical results are not reported in the registry record. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a fraction of the observed effect. The record also distinguishes participant-per-arm planning values from total-event values for time-to-event calculations. These are planning assumptions, not observed trial outcomes or observed power. The registry does not report that these assumptions were part of the study's original design, and the study itself is single-group rather than a two-arm comparison.
General explanation: over-dispersion occurs when variability in count data exceeds what a simple probability model assumes. It can affect uncertainty estimates if the model does not account for that extra variability. The registry does not report a model for over-dispersion, count-data diagnostics, or a dispersion estimate. It is therefore not possible to say whether over-dispersion was assessed or how it would affect the reported endpoint. The lack of a reported primary estimate and interval remains the central limitation for statistical interpretation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures: the primary normal-tissue red-notification rate, the secondary normal-tissue yellow-notification rate, and significant skin irritation or disruption to skin integrity. It lists zero analyses. No outcome results, p-values, or analysis details are reported in the registry record. A multiplicity adjustment or strategy for prioritizing multiple outcomes is not reported either. It is therefore not possible to determine whether inferential testing was planned or conducted, or how any multiple-outcome testing would have been handled.
The primary-outcome description states that three subjects were excluded from analysis because of significant protocol deviations. This is the only stated exclusion detail. The registry does not report what the deviations were, which outcome data were unavailable, or whether exclusions differed across outcomes. It does not describe missing-data patterns, imputation, or sensitivity analyses. Accordingly, the influence of missing or excluded observations cannot be assessed.
The record also does not specify whether the analysis population was defined in advance or how protocol deviations were classified. General statistical explanation: prespecified outcome and population rules help readers understand which observations contribute to each result and reduce ambiguity in interpreting analyses. In this record, the stated exclusions identify a concern relevant to the primary analysis, but the lack of further detail prevents evaluation of its effect. No inference should be drawn about unreported secondary results or adjustments.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Non-Infiltrated Tissue | 0 | 43 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Non-Infiltrated Tissue | 0 of 43 |
For the non-infiltrated-tissue group, the registry lists 43 at risk and 0 affected for serious events. It separately lists 43 at risk and 0 affected for other events. These figures describe the registry's recorded event counts for the group; they do not establish that risk is absent or that no event could occur in other settings. The record lists no top serious-event terms.
The deaths entry is null, rather than a stated zero, so the registry does not report a death count in that field. The record does not provide event-level descriptions or further details about safety ascertainment. It identifies a 24 hour device-monitoring period, but does not give additional follow-up information for adverse events. The secondary outcome list includes significant skin irritation or disruption to skin integrity, but its result is not reported in the registry record. Therefore, the zero event counts should be read narrowly and should not be treated as a complete account of all potential safety outcomes.
12. What the Result Does, and Does Not, Mean
The registry describes a device-validation study that monitored non-infiltrated tissue with the ivWatch Model 400 and identifies the average red-notification rate as its primary endpoint. It gives a 24 hour observation timeframe and specifies that the endpoint was expressed as red notifications per day. These details clarify what the planned summary represents: device alerts during monitoring of tissue characterized as normal.
The primary estimate and its 95% confidence interval are not reported in the registry record. The actual alert rate, its precision, and the degree of variation represented by the observations therefore cannot be determined from the posted results. Results for the listed yellow-notification and skin-irritation outcomes are also not reported. The record's description of the endpoint should not be mistaken for an observed result.
The outcome is an alert frequency, not a count of confirmed infiltrations or a measure of diagnostic accuracy. The record says a red notification signals a need for a clinician to check the site and suggests increased likelihood of possible infiltration relative to a yellow notification. It does not report a reference assessment linking device alerts to confirmed clinical events. It therefore does not establish how often notifications were correct or whether a particular notification represented infiltration.
The single-group design also means there is no comparator-based estimate. The record does not support a claim about differences from another device or monitoring approach. Its safety counts are limited to the event fields reported for this group; the null deaths field and unreported skin outcome should not be interpreted as evidence of no risk. The study can be described as a completed monitoring study, but its outcome magnitude and precision remain unavailable in the registry record.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between measuring a device output and evaluating a clinical outcome. A notification rate describes how often a device generates an alert under specified monitoring conditions. It is a meaningful descriptive endpoint for device behavior, but it does not by itself show whether alerts identify true events. That distinction matters particularly when an alert prompts a clinician to check a site, as the registry describes for red notifications.
The single-group design makes the scope of inference important. It can characterize the monitored group, but it does not provide a comparative estimate against a control group or another device. The absence of a reported primary estimate further limits interpretation: without the mean rate and confidence interval, readers cannot judge either the level of alert activity or its statistical precision.
The analysis exclusions also matter. The record notes three subjects excluded for significant protocol deviations but does not explain what happened or how those exclusions relate to the reported enrollment and summary population. Transparency about analysis populations and missing observations is important because it enables readers to understand which measurements underpin a result and whether exclusions could affect its interpretation.
Finally, the registry lists a confidence-interval method but not the interval itself, and it lists secondary outcomes without their results. This illustrates that reporting the endpoint definition and methods is not a substitute for reporting estimates. For statistical interpretation, the outcome values, uncertainty, analysis details, and relevant safety results are all necessary to understand what the study observed and what remains unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation is that the registry record does not report the primary endpoint estimate or its 95% confidence interval. The key quantity the study was designed to describe—the mean red-notification rate per day—cannot be assessed, and its precision is unknown. Results for the listed secondary outcomes are also absent.
The record describes a single group without allocation or masking and includes no comparator. It consequently cannot support a comparison with another device or group. In addition, the endpoint is a notification rate, and the registry does not report an independent confirmation process for whether alerts corresponded to infiltration. Diagnostic accuracy cannot be evaluated from the stated endpoint alone.
The registry reports enrollment of 43 and describes 40 adult volunteers in its brief summary. It says three subjects were excluded from primary analysis for significant protocol deviations, but does not detail the deviations, the analysis population rules, or the handling of missing observations. This limits assessment of the analysis population and possible exclusion effects.
Further limitations include the absence of reported analysis details despite the record listing zero analyses, no reported multiplicity strategy, and no reported sample-size rationale. The numerical results of the planning illustration are not reported in the registry record, and its assumptions should not be mistaken for the study's original design. Safety reporting is also limited: the group event counts are listed, but the deaths field is null and the skin outcome result is unavailable. The record provides no additional follow-up or event-level detail.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: ivWatch Model 400: Device Validation for Non-Infiltrated Tissues — NCT02120443.
- Registry record last updated 2014-07-02; status last verified 2014-06.
- Results first posted 2014-06-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed, single-group study of the ivWatch Model 400 monitoring non-infiltrated tissue at a common peripheral IV site over 24 hours. It lists enrollment of 43 and describes 40 adult volunteers in the brief summary. Three subjects were excluded from primary-outcome analysis because of significant protocol deviations.
The primary endpoint was the mean red-notification rate per day, with a 95% confidence interval calculated using the Clopper-Pearson method. The registry lists two secondary outcomes, but no outcome estimates or analyses are reported. The serious-event and other-event counts are each listed as 0 affected among 43 at risk; the deaths field is null. The primary numerical result, its uncertainty, and secondary outcome results are not reported in the registry record.